Barrier Film vs. Standard Skin Care in Preventing Dermatitis in Women With Breast Cancer Receiving Radiation

NCT01762020 | Completed Phase 3 DMC

• 1 other identifier: London Regional Cancer Program
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effectiveness of preventing Grade II or greater radiation dermatitis induced by adjuvant radiation therapy in women with breast cancer.

Conditions

Breast Cancer; Dermatitis

Keywords

Women with Breast Cancer; Receiving Adjuvant Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• Percent of patients developing modified Radiation Therapy Oncology Group(RTOG) Visual Assessment Score Grade II or greater radiation dermatitis induced by adjuvant radiation therapy in women with breast cancer

  modified RTOG Visual Assessment Score

  3 1/2 - 5 weeks of radiation treatment.

Secondary Outcomes (2)

• Time to develop modified Radiation Therapy Oncology Group Visual Assessment Score Grade I, II, and/or Grade III radiation dermatitis

  3 1/2 - 5 weeks of radiation treatment.

• Absolute cost of barrier film and standard treatment care

  3 1/2 - 5 weeks

Study Arms (2)

3M Cavilon No Sting Barrier Film

ACTIVE COMPARATOR

Two of four regions of the breast will be randomly chosen to receive 3M Cavilon No Sting Barrier Film treatment twice per week.

Device: 3M Cavilon No Sting Barrier Film

Standard preparations

PLACEBO COMPARATOR

Standard treatment

Drug: Standard Preparation

Interventions

3M Cavilon No Sting Barrier Film DEVICE

Half the breast will receive 3M Cavilon No Sting Barrier Film and one half will receive standard skin care

Also known as: Cavilon no-sting

3M Cavilon No Sting Barrier Film

Standard Preparation DRUG

standard creams

Also known as: standard creams

Standard preparations

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients between 18 and 80 years of age at the time of enrollment
• Histopathologically or cytologically confirmed diagnosis of breast cancer
• Completed lumpectomy and sentinel lymph node biopsy or axillary lymph node dissection
• Signed and dated ethics-approved informed consent form prior to any study procedures
• Ability to comply with the requirements of the study
• Scheduled adjuvant radiation therapy treatment

You may not qualify if:

• Clinical or radiological evidence of local recurrence or metastatic disease
• Previous history of radiation therapy to ipsilateral axilla and/or breast area
• Planned boost of radiation Dementia, psychoses, or other significant impairment of mental status that would prohibit the understanding and giving of informed consent or the participation in self-care or toxicity reporting
• Any significant history or concurrent disease which, in the judgment of the Investigator would make the patient inappropriate for entry to this study
• History of contraindications of radiation such as scleroderma

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Regional Cancer Program, London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Dermatitis

Interventions

Reference Standards

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Weights and Measures; Investigative Techniques

Study Officials

• Michael Lock, MD, FRCPC

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: within patient randomization. One half of breast received Cavilon and other receives standard of care treatment. Care provider is blinded as to portion receiving treatment.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: within patient randomization of Cavilon skin spray

Study Record Dates

• First Submitted: January 3, 2013
• First Posted: January 7, 2013
• Study Start: January 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: March 8, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)